27 CIED advisories: impact and effect on pacing clinic and patient care. (May 2019)

• Record Type: Journal Article
• Authors: anderson, sarah; Newsholme, Anne Marie; Veasey, Rick; Patel, Nikhil
• Is Part Of: Heart. Volume 105(2019)Supplement 6
• Page Start: A24
• Page End: A25
• Publication Date: 2019-05
• Subjects: cardiac implantable electronic devices -- field safety notices -- device complications; Heart -- Diseases -- Treatment -- Periodicals; Cardiology -- Periodicals; 616.12
• DOI: 10.1136/heartjnl-2019-BCS.26
• Languages: English
• ISSNs: 1355-6037

Abstract

Abstract : Introduction: Implanting of cardiac implantable electrical devices (CIEDs) has become routine practice in the majority of acute hospitals. The numbers of patients receiving CIEDs are increasing rapidly due to a growing elderly population and adherence to NICE guidance. CIEDs have been subject to safety advisories potentially resulting in intensive patient follow up. Recent experience indicates that the number of advisories we deal with is increasing. We sought to quantify the additional burden this has placed on the cardiac device clinic and patients. Methods: A retrospective review was undertaken on all advisories & recalls issued by device company field safety notices and the MHRA website from 2008 to 2018. We assessed 24 hardware and 13 software advisories Then the number of patients affected by each at Eastbourne District General Hospital (EDGH) were recorded (n=1720), and the impact on the device clinic (additional hours) was calculated. Results: 5188 patients in total were seen in our device clinic over 10 years. 1720 patients were found to be subject to an advisory. Of these patients, 1234 were software advisories and 486 mechanical advisories. This resulted in 1237 patients requiring device follow up to be intensified. One hour of additional support was calculated per patient advisory. This was made up of 20 minutes for the initial interrogation and 40 minutes for extra administration and subsequent follow up if required. An average of 1720 hours was spent on patient advisories over a 10-year period resulting in one extra clinic session per week. Conclusion: We calculated that 33% of all patients seen in clinic in the last 10 years have been subject to an advisory. On average over the ten year period this has required an additional 1720 hours per patient advisory resulting in an extra whole physiology clinic session per week. This represents a significant challenge to the Pacing workforce. Our data shows that there are more software related advisories than hardware advisories. Software solutions resolve the issue but are often delayed. Device advisories have now become a major complication in pacemaker implantation with a significantly higher frequency than procedural complications. One could consider adding this finding to the discussion with the patient prior to device implant. Conflict of Interest: None at time of writing